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Insurance carriers may vary with their processes and procedures for covering SPINRAZA, so your practice or facility may want to establish a protocol to help you obtain access to, and reimbursement for, SPINRAZA.

The resources in this section will help you acquire SPINRAZA for your patients and provide you with information and tools to assist with the reimbursement process. There are links provided for you to download each resource.

OBTAINING ACCESS FOR SPINRAZA 

Obtaining approval for your patient’s treatment for spinal muscular atrophy (SMA) often requires your practice or facility to complete several steps, including conducting a thorough Benefit Investigation to determine if an authorization and/or medical exception is needed prior to treatment approval. In addition, your practice or facility may need to coordinate with a specialty pharmacy to ensure all payer approvals are obtained and the medication is shipped.

Biogen has developed multiple resources to assist your practice or facility in navigating the approval process for SPINRAZA once treatment has been prescribed.

PROCESS OVERVIEW

Includes a step-by-step process for the management of the reimbursement process for SPINRAZA, and a list of available access resources for SPINRAZA to support your patients

WELCOME LETTER

Provides an overview of the access and reimbursement resources for SPINRAZA

FACT SHEET FOR SPINRAZA

Contains information about SPINRAZA, including product and procedure codes that may be required

FAQs ABOUT SMA AND SPINRAZA

Includes the answers to questions that your office may have about SMA and SPINRAZA

SPINRAZA CLINICAL OVERVIEW

Provides information about the multiple clinical studies of SPINRAZA, including the trial designs and efficacy and safety results

TIPS TO SUCCESSFULLY COMPLETING A SPINRAZA START FORM

Explains the SPINRAZA Start Form and provides tips on how to complete each section so that your patients can enroll in Biogen support services

GUIDE TO PRIOR AUTHORIZATION (PA) SUBMISSIONS

Provides steps and tips when submitting a PA

GUIDE TO REQUESTING A MEDICAL EXCEPTION (ME)

Contains tips for submitting an ME

SAMPLE LETTER OF MEDICAL NECESSITY

Provides a Word template of a sample letter to use when requesting an ME for a patient

INSURANCE CARRIER CONTACT SHEET

Provides a template to help your office record contact information for the insurance carriers that are contacted the most

UNDERSTANDING MEDICAL VS PHARMACY BENEFIT

Includes overview information about distinguishing between medical and pharmacy benefit cards

PROCURING SPINRAZA

SPINRAZA can be ordered only directly through a specialty distributor (SD), CuraScript SD, or from a specialty pharmacy, Accredo Specialty Pharmacy. CuraScript SD/Accredo Specialty Pharmacy have extensive experience handling and distributing specialty pharmacy products for a variety of chronic and rare conditions. Ordering SPINRAZA is done as any other product that is administered at your site of care. Once the order for SPINRAZA has been submitted to your pharmacy or procurement department, the order for SPINRAZA will be placed. 

DISTRIBUTION MODEL OVERVIEW

Provides an overview of the process for ordering SPINRAZA through CuraScript SD/Accredo Specialty Pharmacy

NAVIGATING REIMBURSEMENT FOR SPINRAZA

When a patient has been administered the SPINRAZA injection and/or a related service, your practice or facility may submit a claim to the patient’s insurance plan. Items included on your claim may depend on the site of care and the billing entity. Coding and billing recommendations may vary by payer. Your practice or facility should check directly with the patient’s payer(s) to verify specific coding and billing requirements.

To assist you in navigating the access and reimbursement process, we have developed a comprehensive reimbursement guide that includes the steps for starting a patient on therapy, as well as information needed to submit a claim for reimbursement. There are also separate resources that highlight a sample claim form and relevant codes for SPINRAZA, which you can download for easy reference.

A GUIDE TO SPINRAZA REIMBURSEMENT

Provides a comprehensive guide of the reimbursement considerations for SPINRAZA

SAMPLE CLAIM FORMS

Contains sample claim forms such as CMS-145/UB-04 and CMS-1500, and includes codes used for SPINRAZA

RELEVANT CODES

Contains a summary of relevant codes that may be required for SPINRAZA and related administration services

OBTAINING ACCESS FOR SPINRAZA 

Obtaining approval for your patient’s treatment for spinal muscular atrophy (SMA) often requires your practice or facility to complete several steps, including conducting a thorough Benefit Investigation to determine if an authorization and/or medical exception is needed prior to treatment approval. In addition, your practice or facility may need to coordinate with a specialty pharmacy to ensure all payer approvals are obtained and the medication is shipped.

Biogen has developed multiple resources to assist your practice or facility in navigating the approval process for SPINRAZA once treatment has been prescribed.

PROCESS OVERVIEW

Includes a step-by-step process for the management of the reimbursement process for SPINRAZA, and a list of available access resources for SPINRAZA to support your patients

WELCOME LETTER

Provides an overview of the access and reimbursement resources for SPINRAZA

FACT SHEET FOR SPINRAZA

Contains information about SPINRAZA, including product and procedure codes that may be required

FAQs ABOUT SMA AND SPINRAZA

Includes the answers to questions that your office may have about SMA and SPINRAZA

SPINRAZA CLINICAL OVERVIEW

Provides information about the multiple clinical studies of SPINRAZA, including the trial designs and efficacy and safety results

TIPS TO SUCCESSFULLY COMPLETING A SPINRAZA START FORM

Explains the SPINRAZA Start Form and provides tips on how to complete each section so that your patients can enroll in Biogen support services

GUIDE TO PRIOR AUTHORIZATION (PA) SUBMISSIONS

Provides steps and tips when submitting a PA

GUIDE TO REQUESTING A MEDICAL EXCEPTION (ME)

Contains tips for submitting an ME

SAMPLE LETTER OF MEDICAL NECESSITY

Provides a Word template of a sample letter to use when requesting an ME for a patient

INSURANCE CARRIER CONTACT SHEET

Provides a template to help your office record contact information for the insurance carriers that are contacted the most

UNDERSTANDING MEDICAL VS PHARMACY BENEFIT

Includes overview information about distinguishing between medical and pharmacy benefit cards

PROCURING SPINRAZA 

SPINRAZA can be ordered only directly through a specialty distributor (SD), CuraScript SD, or from a specialty pharmacy, Accredo Specialty Pharmacy. CuraScript SD/Accredo Specialty Pharmacy have extensive experience handling and distributing specialty pharmacy products for a variety of chronic and rare conditions. Ordering SPINRAZA is done as any other product that is administered at your site of care. Once the order for SPINRAZA has been submitted to your pharmacy or procurement department, the order for SPINRAZA will be placed. 

DISTRIBUTION MODEL OVERVIEW

Provides an overview of the process for ordering SPINRAZA through CuraScript SD/Accredo Specialty Pharmacy

NAVIGATING REIMBURSEMENT FOR SPINRAZA 

When a patient has been administered the SPINRAZA injection and/or a related service, your practice or facility may submit a claim to the patient’s insurance plan. Items included on your claim may depend on the site of care and the billing entity. Coding and billing recommendations may vary by payer. Your practice or facility should check directly with the patient’s payer(s) to verify specific coding and billing requirements.

To assist you in navigating the access and reimbursement process, we have developed a comprehensive reimbursement guide that includes the steps for starting a patient on therapy, as well as information needed to submit a claim for reimbursement. There are also separate resources that highlight a sample claim form and relevant codes for SPINRAZA, which you can download for easy reference.

A GUIDE TO SPINRAZA REIMBURSEMENT

Provides a comprehensive guide of the reimbursement considerations for SPINRAZA

SAMPLE CLAIM FORMS

Contains sample claim forms such as CMS-145/UB-04 and CMS-1500, and includes codes used for SPINRAZA

RELEVANT CODES

Contains a summary of relevant codes that may be required for SPINRAZA and related administration services

Key Icon

For any access, reimbursement, or distribution questions about SPINRAZA, contact your Biogen representative or call a Lead Case Manager (LCM) at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM - 8:00 PM ET, to get more information about SMA360o support services.

Photo of Emma aged 7 years old with Type 3 SMA kissing her sister, Ruby aged 4 years old with Type 2 SMA
Emma
age 7

Later-onset (Type 3) SMA treated with SPINRAZA

Ruby
age 4

Later-onset (Type 2) SMA treated with SPINRAZA

Individual results may vary based on several factors, including severity of disease and duration of therapy.

INDICATION

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

IMPORTANT SAFETY INFORMATION

Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Patients may be at increased risk of bleeding complications. Perform a platelet count and coagulation laboratory testing at baseline and prior to each administration of SPINRAZA and as clinically needed.

In a clinical study, 11% of SPINRAZA-treated patients with normal or above normal platelet levels at baseline developed a platelet level below the lower limit of normal compared to zero sham-procedure control patients. No patient had a platelet count <50,000 cells per mcL and no patient developed a sustained low platelet count despite continued drug exposure.

Renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides.

SPINRAZA is present in and excreted by the kidney. In a clinical study (mean treatment exposure 7 months), 33% of SPINRAZA-treated patients had elevated urine protein, compared to 20% of sham-control patients. In a group of later-onset SMA patients (mean treatment exposure 34 months), 69% had elevated urine protein.

No elevations in serum creatinine or cystatin C were observed in studies with SPINRAZA. Conduct quantitative spot urine protein testing (preferably using a first morning urine specimen) at baseline and prior to each dose of SPINRAZA. For urinary protein concentration >0.2 g/L, consider repeat testing and further evaluation.

Severe hyponatremia was reported in an infant treated with SPINRAZA requiring salt supplementation for 14 months.

Cases of rash were reported in patients treated with SPINRAZA.

SPINRAZA may cause a reduction in growth as measured by height when administered to infants, as suggested by observations from the controlled study. It is unknown whether any effect of SPINRAZA on growth would be reversible with cessation of treatment.

The most common adverse reactions that occurred in the controlled study in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients were upper respiratory infection (39% vs 34%), lower respiratory infection (43% vs 29%), and constipation (30% vs 22%). Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (14%) than in control patients (5%). Because patients in the controlled study were infants, adverse reactions that are verbally reported could not be assessed in this study. In the open-label studies, the most common adverse events in later onset patients were headache (50%), back pain (41%) and post lumbar puncture syndrome (41%).

Please see full Prescribing Information for additional Important Safety Information.

As a courtesy, our full Prescribing Information is also available en Español. For prescribing decisions, please refer to official approved labeling.